RecruitingNCT04849481

The Research Plan of Taiwan Precision Medicine

The Research Plan of Taiwan Precision Medicine: Lung Cancer


Sponsor

National Health Research Institutes, Taiwan

Enrollment

550 participants

Start Date

Jun 23, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Non-small-cell lung cancer (NSCLC) is one of the top three most common cancers in Taiwan. Targetable driver mutations in NSCLC are more prevalent in Asian population compared to those in Western population, which offers chances to apply suitable targeted therapies worldwide. For patients who failed to the treatment of tyrosine kinase inhibitors (TKIs), the genetic mutations from next-generation sequencing (NGS) reports can serve as the reference of treatment selection. Moreover, the expression of PD-1/PD-L1 serves as a helpful indicator for the response of immune checkpoint inhibitors (ICIs). On the other hand, patients with wild-type EGFR/ALK mutations and PD-L1-negative NSCLC who received chemotherapy had relative poorer survival than those received suitable targeted therapies and ICIs. To further elucidate the underlying molecular genomic aberrations, as well as the clinical demographics and therapeutic outcomes in above subpopulations, it is necessary to have a national, multi-centers and population-focused research project to collect data completely. Tumor tissue will be collected from advanced NSCLC patients with wild-type EGFR/ALK or with EGFR/ALK mutation after resistant to TKIs for next-generation sequencing analysis in a platform of data storage and sharing. The purpose of the precision medicine project is to establish tumor molecular profiling of specific NSCLC populations in Taiwan, to facilitate patients to have corresponding potential targeted therapeutics and suitable clinical trials, and to extend the median overall survival.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This is a precision medicine study in Taiwan that analyzes tumor tissue samples from patients with lung cancer to identify genetic profiles that may predict which targeted treatments will work best — especially for patients whose cancer has not responded to standard therapies. **You may be eligible if:** - You are 20 or older - You have been diagnosed with certain types of lung cancer (adenocarcinoma, squamous cell carcinoma, or other specified types) - For squamous cell carcinoma: you are a non-smoker or light smoker (fewer than 10 cigarettes per day) - For advanced adenocarcinoma with or without EGFR/ALK mutations: you have received up to two prior lines of treatment - For adenocarcinoma with specific EGFR mutations (exon 20 insertion): you may have received up to four lines of prior treatment - You have tumor tissue available after previous treatment - You have a life expectancy of more than 3 months **You may NOT be eligible if:** - You are unable to provide a complete medical history - You have no tumor tissue available for genetic testing - You are unlikely to comply with follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(13)

Chang Gung Medical Foundation

Chiayi City, Taiwan

Dalin Tzu Chi Hospital

Dalin, Taiwan

Chang Gung Medical Foundation

Kaohsiung City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University-Shuang Ho Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Taoyuan General Hospital

Taoyuan, Taiwan

View Full Details on ClinicalTrials.gov

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NCT04849481


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